LogoFDA 510(k) Search
Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K010232
    Device Name
    PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    P.T. HEALTHCARE GLOVINDO
    Date Cleared
    2001-09-21

    (240 days)

    Product Code
    LZA
    Regulation Number
    880.6250
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
    Ask a Question

    Ask a specific question about this device

    K Number
    K974442
    Device Name
    PRE-POWDERED NITRILE EXAMINATION GLOVES
    Manufacturer
    P.T. LATEXINDO TOBAPERKASA
    Date Cleared
    1998-01-05

    (41 days)

    Product Code
    LZY
    Regulation Number
    888.3360
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

    Device Description

    Pre-powdered Nitrile Examination Gloves

    AI/ML Overview

    The document is a 510(k) clearance letter from the FDA for "Pre-Powdered Nitrile Examination Gloves" manufactured by P.T. Latexindo Tobaperkasa. It states that the device is substantially equivalent to devices marketed before May 28, 1976, and therefore can be marketed.

    This document is a regulatory clearance letter, not a study report or technical specification detailing performance criteria and a study proving those criteria were met. Therefore, none of the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth, expert involvement, adjudication, or MRMC studies can be extracted from this document.

    The letter confirms the device's classification and substantial equivalence but does not provide the technical data or study results that would typically be included in a submission demonstrating performance against specific acceptance criteria.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1